Transgender Men, Non-binary Persons and Testosterone Treatment BODY IDENTITY CLINIC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Transgenderism. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Masculinizing Testosterone Treatment and Effects on Preclinical Cardiovascular Disease, Muscle Strength and Power, Aggression, Physical Fitness and Respiratory Function in Transgender Men,Body Identity Clinic (BIC)
Overview
The aim of this study is to investigate transgender men and non-binary persons before and during testosterone treatment. The study will focus on: * Cardiovascular status * Muscle strenght and power * Aggression and quality of life * Cardiac and respiratory function
Detailed description
Introduction: The number of individuals with gender dysphoria seeking gender-affirming treatment is increasing. The short- and long-term effects of masculinizing treatment with testosterone are debated as serum testosterone increase up to 20-fold compared to cisgender women. We hypothesize that, testosterone treatment is associated with non-calcified coronary plaque (NCP) development in transgender men.
Methods and analyses: Prospective, single-center, observational cohort study at the Body Identity Clinic (BIC), Odense University Hospital, Denmark, where all investigations are performed at inclusion and after 1, 3, 5 and 10 years of testosterone therapy.
Ethics and dissemination: The Regional Committees on Health Research Ethics for Southern Denmark (S-20190108) and the Danish Data Protection Agency approved the study (19/27572). Signed informed consent will be obtained from all participants. All findings will be published in peer-reviewed journals or at scientific conferences.
Primary outcome measures
- Effect of testosterone on devellopment of plaques in the heart [Time frame: 10 years]
Secondary outcome measures (12)
- Calcium score [Time frame: 10 years]
- Change in muscle strength and power [Time frame: 10 years]
- Effect of transgender treatment on quality of life [Time frame: 10 years]
- Effect of transgender treatment on aggression [Time frame: 10 years]
- Changes in maximal oxygen consumption during transgender treatment [Time frame: 10 years]
- Heart function [Time frame: 10 years]
- Respiratory function [Time frame: 10 years]
- Levels of testosterone, estradiol and cortisol [Time frame: 10 years]
- circulating markers of inflammation [Time frame: 10 years]
- circulating markers of cardiovascular risk [Time frame: 10 years]
- Assessment of cortisol/cortisone [Time frame: 10 years]
- Change in lean body mass [Time frame: 10 years]
Eligibility criteria
Inclusion criteria
Transgender men
Exclusion criteria
none
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Denmark · 1 center
- Odense University Hospital — Odense
Publications
- Lehmann Christensen L, Glintborg D, Taulbjerg Kristensen T, Diederichsen A, T'Sjoen G, Frystyk J, Skovsager Andersen M. Masculinising testosterone treatment and effects on preclinical cardiovascular disease, muscle strength and power, aggression, physical fitness and respiratory function in transgender men: protocol for a 10-year, prospective, observational cohort study in Denmark at the Body Iden PMID 33376186
Identifiers
NCT: NCT04254354 · BICTX01